Dataset Information

Protocol for a randomized controlled trial evaluating the impact of the Nurse-Family Partnership's home visiting program in South Carolina on maternal and child health outcomes.

ABSTRACT:

Background

Policy-makers are increasingly seeking rigorous evidence on the impact of programs that go beyond typical health care settings to improve outcomes for low-income families during the critical period around the transition to parenthood and through early childhood.

Methods

This study is a randomized controlled trial evaluating the impact of the Nurse-Family Partnership's expansion in South Carolina. The scientific trial was made possible by a "Pay for Success" program embedded within a 1915(b) Waiver from Medicaid secured by the South Carolina Department of Health and Human Services. This protocol describes study procedures and defines primary and secondary health-related outcomes that can be observed during the intervention period (including pregnancy through the child's first 2 years of life). Primary study outcomes include (1) a composite indicator for adverse birth outcomes including being born small for gestational age, low birth weight (less than 2500 g), preterm birth (less than 37 weeks' gestation), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life), (2) a composite outcome indicating health care utilization or mortality associated with major injury or concern for abuse or neglect occurring during the child's first 24 months of life, and (3) an indicator for an inter-birth interval of < 21 months. Secondary outcomes are defined similarly in three domains: (1) improving pregnancy and birth outcomes, (2) improving child health and development, and (3) altering the maternal life course through changes in family planning.

Discussion

Evidence from this trial on the impact of home visiting services delivered at scale as part of a Medicaid benefit can provide policy-makers and stakeholders with crucial information about the effectiveness of home visiting programs in improving health and well-being for low-income mothers and children and about novel financing mechanisms for cross-silo interventions.

Trial registration

The trial was registered prospectively on the American Economic Association Trial Registry (the primary registry for academic economists doing policy trials) on 16 February 2016 ( AEARCTR-0001039 ). ClinicalTrials.gov NCT03360539 . Registered on 28 November 2017.

SUBMITTER: McConnell MA

PROVIDER: S-EPMC7716290 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:To test the efficacy of a nurse home visiting program (HVP) on child development, maternal and environmental outcomes in the first years of life. We conducted a randomized controlled trial to test the efficacy of Primeiros Laços, a nurse HVP for adolescent mothers living in a poor urban area of São Paulo, Brazil. Eighty adolescent mothers were included and randomized to receive either Primeiros Laços (intervention group, n = 40) or healthcare as usual (control group, n = 40). Primeiros Laços is a home visiting intervention delivered by trained nurses that starts during the first 16 weeks of pregnancy and continues to the child's age of 24 months. Participants were assessed by blind interviewers at 8-16 weeks of pregnancy (baseline), 30 weeks of pregnancy, and 3, 6, 12, and 24 months of child's age. We assessed oscillatory power in the mid-range alpha frequency via electroencephalography when the children were aged 6 months. Child development was measured by the Bayley Scales of Infant Development Third Edition (BSID-III). Weight and length were measured by trained professionals and anthropometric indexes were calculated. The home environment and maternal interaction with the child was measured by the Home Observation and Measurement of the Environment. Generalized estimating equation models were used to examine intervention effects on the trajectories of outcomes. Standardized effect sizes (Cohen's d) were calculated using marginal means from endpoint assessments of all outcomes. The trial was registered at clinicaltrial.gov: NCT02807818. Our analyses showed significant positive effects of the intervention on child expressive language development (coefficient = 0.89, 95% CI [0.18, 1.61], p = 0.014), maternal emotional/verbal responsivity (coefficient = 0.97, 95% CI [0.37, 1.58], p = 0.002), and opportunities for variety in daily stimulation (coefficient = 0.37, 95% CI [0.09, 0.66], p = 0.009). Standardized effect sizes of the intervention were small to moderate. Primeiros Laços is a promising intervention to promote child development and to improve the home environment of low-income adolescent mothers. However, considering the limitations of our study, future studies should be conducted to assess Primeiros Laços potential to benefit this population.Clinical Trial Registration: The study was registered at clinicaltrial.gov (Registration date: 21/06/2016 and Registration number: NCT02807818).

Project description:ImportanceThe Family Connects (FC) program, a community-wide nurse home visiting program for newborns, has been shown to provide benefits for children and families through the first 2 years of life. Potential longer-term outcomes for child well-being remain unknown.ObjectiveTo determine the effect of randomization to FC on child maltreatment investigations and emergency medical care through 5 years of age.Design, setting, and participantsIn this randomized clinical trial, families of all 4777 resident births in Durham County, North Carolina, from July 1, 2009, to December 31, 2010, were randomly assigned to receive the FC program or treatment as usual. Impact evaluation was on an intent-to-treat basis and focused on a subsample of 549 families randomly selected from the full population and included review of hospital and Child Protective Services (CPS) administrative records. Statistical analysis was conducted from November 6, 2020, to April 25, 2021.InterventionsThe FC programs includes 1 to 3 nurse home visits beginning at the infant age of 3 weeks designed to identify family-specific needs, deliver education and intervention, and connect families with community resources matched to their needs. Ongoing program engagement with service professionals and an electronic resource directory facilitate effective family connections to the community.Main outcomes and measuresTwo primary trial outcomes were CPS-recorded child maltreatment investigations and emergency medical care use based on hospital records.ResultsOf the 4777 randomized families, 2327 were allocated to the intervention, and 2440 were allocated to services as usual. Among the children in the full study population, 2380 (49.8%) were female, 2397 (50.2%) were male, and 3359 (70.3%) were from racial/ethnic minority groups; of the 531 children included in the impact evaluation follow-up, 284 (53.5%) were female, 247 (46.5%) were male, and 390 (73.4%) were from racial/ethnic minority groups. Negative binomial models indicated that families assigned to FC had 39% fewer CPS investigations for suspected child maltreatment through 5 years of age (95% CI, -0.80 to 0.06; 90% CI, -0.73 to -0.01; control = 44 total investigations per 100 children and intervention = 27 total investigations per 100 children); intervention effects did not differ across subgroups. Families assigned to FC also had 33% less total child emergency medical care use (95% CI, -0.59 to -0.14; 90% CI, -0.55 to -0.18; control = 338 visits and overnight hospital stays per 100 children and intervention = 227 visits and overnight hospital stays per 100 children). Positive effects held across birth risk, child health insurance, child sex, single-parent status, and racial/ethnic groups. Effects were larger for nonminority families compared with minority families.Conclusions and relevanceThe findings of this randomized clinical trial suggest that, when implemented with high quality and broad reach, a brief postpartum nurse home visiting program can reduce population rates of child maltreatment and emergency medical care use in early childhood.Trial registrationClinicalTrials.gov Identifier: NCT01406184.

Project description:In 2019, the South Korean government established a plan to develop home visitation services for pregnant women and women with children below the age of 24 months and expand the services nationwide. Therefore, a national survey was needed to provide relevant information for the policy decision of whether to implement universal home visitation services by nurses for families with young children. To determine home visitation service needs in South Korea, 804 women who were pregnant or had children below the age of 24 months were selected as survey participants through stratified random sampling by region reflecting geographical distribution in numbers of births. Of them, 614 responded to survey questionnaires delivered via email. After excluding surveys with too short of a response time, extreme values, and incomplete answers, 500 participants’ responses were analyzed. Participants indicated whether they supported the provision of home visitation services and whether they were willing to utilize home visitation services. The survey also elicited responses regarding the level of needs for individual service items that could be delivered by nurses during home visits. The fieldwork was conducted by a consulting and research firm. The differences in whether respondents supported nurse home visitation services and intended to use nurse home visitation services according to mothers’ characteristics were examined using the chi-square test. In total, 88.0% of survey participants supported nurse home visitation services, and 81.2% indicated that they intended to receive the services. Most pregnant women and women with children below the age of 24 months responded positively to the various prenatal or postpartum services that nurses could provide during home visits. The percentages of support for the services and intention to use services were generally high among subgroups according to mothers’ characteristics. Therefore, universal home visitation services by nurses during pregnancy and in the postnatal period would be received well by Korean women.

Project description:BackgroundInterventions are needed to reduce poor perinatal health. We trained community health workers (CHWs) as home visitors to address maternal/infant risks.MethodsIn a cluster randomised controlled trial in Cape Town townships, neighbourhoods were randomised within matched pairs to 1) the control, healthcare at clinics (n = 12 neighbourhoods; n = 594 women), or 2) a home visiting intervention by CBW trained in cognitive-behavioural strategies to address health risks (by the Philani Maternal, Child Health and Nutrition Programme), in addition to clinic care (n = 12 neighbourhoods; n = 644 women). Participants were assessed during pregnancy (2% refusal) and 92% were reassessed at two weeks post-birth, 88% at six months and 84% at 18 months later. We analysed 32 measures of maternal/infant well-being over the 18 month follow-up period using longitudinal random effects regressions. A binomial test for correlated outcomes evaluated overall effectiveness over time. The 18 month post-birth assessment outcomes also were examined alone and as a function of the number of home visits received.ResultsBenefits were found on 7 of 32 measures of outcomes, resulting in significant overall benefits for the intervention compared to the control when using the binomial test (p = 0.008); nevertheless, no effects were observed when only the 18 month outcomes were analyzed. Benefits on individual outcomes were related to the number of home visits received. Among women living with HIV, intervention mothers were more likely to implement the PMTCT regimens, use condoms during all sexual episodes (OR = 1.25; p = 0.014), have infants with healthy weight-for-age measurements (OR = 1.42; p = 0.045), height-for-age measurements (OR = 1.13, p<0.001), breastfeed exclusively for six months (OR = 3.59; p<0.001), and breastfeed longer (OR = 3.08; p<0.001). Number of visits was positively associated with infant birth weight ≥2500 grams (OR = 1.07; p = 0.012), healthy head-circumference-for-age measurements at 6 months (OR = 1.09, p = 0.017), and improved cognitive development at 18 months (OR = 1.02, p = 0.048).ConclusionsHome visits to neighbourhood mothers by CHWs may be a feasible strategy for enhancing maternal/child outcomes. However, visits likely must extend over several years for persistent benefits.Trial registrationClinicalTrials.gov NCT00996528.